Atrial arrhythmia episode detection in a cardiac medical device

ABSTRACT

A method and medical device for detecting a cardiac event that includes sensing a cardiac signal, determining RR-intervals in response to the sensed cardiac signal, detecting a cardiac event in response to the RR-intervals, iteratively sensing a predetermined number of P-waves in response to detecting the cardiac event, and confirming the cardiac event in response to the iteratively sensed P-waves.

RELATED APPLICATION

Cross-reference is hereby made to commonly assigned U.S. patentapplication Ser. No. ______ filed on even date herewith (Attorney docketnumber C00005676.USU2) entitled “ATRIAL ARRHYTHMIA EPISODE DETECTION INA CARDIAC MEDICAL DEVICE”, and U.S. patent application Ser. No. ______,filed on even date herewith (Attorney docket number C00005676.USU3)entitled “ATRIAL ARRHYTHMIA EPISODE DETECTION IN A CARDIAC MEDICALDEVICE”, and incorporated by reference in it's entirety.

TECHNICAL FIELD

The disclosure relates generally to cardiac medical devices and, inparticular, to a method for detecting atrial arrhythmia episodes duringventricular pacing in a cardiac medical device.

BACKGROUND

During normal sinus rhythm (NSR), the heart beat is regulated byelectrical signals produced by the sino-atrial (SA) node located in theright atrial wall. Each atrial depolarization signal produced by the SAnode spreads across the atria, causing the depolarization andcontraction of the atria, and arrives at the atrioventricular (A-V)node. The A-V node responds by propagating a ventricular depolarizationsignal through the bundle of His of the ventricular septum andthereafter to the bundle branches and the Purkinje muscle fibers of theright and left ventricles.

Atrial tachyarrhythmia includes the disorganized form of atrialfibrillation and varying degrees of organized atrial tachycardia,including atrial flutter. Atrial fibrillation (AF) occurs because ofmultiple focal triggers in the atrium or because of changes in thesubstrate of the atrium causing heterogeneities in conduction throughdifferent regions of the atria. The ectopic triggers can originateanywhere in the left or right atrium or pulmonary veins. The AV nodewill be bombarded by frequent and irregular atrial activations but willonly conduct a depolarization signal when the AV node is not refractory.The ventricular cycle lengths will be irregular and will depend on thedifferent states of refractoriness of the AV-node.

As more serious consequences of persistent atrial arrhythmias have cometo be understood, such as an associated risk of relatively more seriousventricular arrhythmias and stroke, there is a growing interest inmonitoring and treating atrial arrhythmias.

Methods for discriminating arrhythmias that are atrial in origin fromarrhythmias originating in the ventricles have been developed for use indual chamber implantable devices wherein both an atrial EGM signal and aventricular EGM signal are available. Discrimination of arrhythmias canrely on event intervals (PP intervals and RR intervals), event patterns,and EGM morphology. Such methods have been shown to reliablydiscriminate ventricular arrhythmias from supra-ventricular arrhythmias.In addition, such methods have been developed for use in single chamberimplantable devices, subcutaneous implantable devices, and externalmonitoring devices, where an adequate atrial EGM signal havingacceptable signal-to-noise ratio is not always available for use indetecting and discriminating atrial arrhythmias. However, such singlechamber devices have been designed to monitor AF during non-pacedventricular rhythm. An exemplary method and device for detectingarrhythmias during ventricular pacing was recently described in commonlyassigned U.S. patent application Ser. No. 14/520,798 to Cao et. al.,U.S. patent application Ser. No. 14/520,847 to Cao et al., and U.S.patent application Ser. No. 14/520,938 to Cao et al. What is needed,therefore, is a method for improving specificity of monitoring atrialarrhythmias during a ventricular paced rhythm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an exemplary medical device fordetecting arrhythmia during ventricular pacing according to anembodiment of the present disclosure.

FIG. 2 is a functional schematic diagram of the medical device of FIG.1.

FIG. 3 is a schematic exemplary diagram of classifying of cardiac eventsin a cardiac medical device according to an embodiment of the presentdisclosure.

FIG. 4 is a diagram of an exemplary two-dimensional histogramrepresenting a Lorenz plot area for identifying cardiac events.

FIG. 5 is a flowchart of a method of generating a template fordetermining atrial fibrillation events in a medical device according toan embodiment of the present disclosure.

FIGS. 6A and 6B are schematic diagrams of identifying a P-wave portionof a sensed cardiac signal in a medical device according to anembodiment of the present disclosure.

FIG. 7 is a graphical representation of determining of a P-wave windowstart point based on a sensed R-wave for generating a template duringdetermining of atrial fibrillation events in a medical device accordingto an embodiment of the present disclosure.

FIGS. 8A and 8B are schematic diagrams of determining of P-wave templateparameters in a medical device according to an embodiment of the presentdisclosure.

FIG. 9 is a flowchart of a method for generating a template fordetermining an atrial fibrillation event in a medical device accordingto an embodiment of the present disclosure.

FIG. 10 is a flowchart of determining P-wave matching in a medicaldevice according to an embodiment of the present disclosure.

FIGS. 11A and 11B are flowcharts of detecting an atrial arrhythmia in acardiac medical device according to an embodiment of the presentdisclosure.

FIG. 12 is a flowchart of a method of detecting an atrial arrhythmia ina medical device according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following description, references are made to illustrativeembodiments for carrying out the methods described herein. It isunderstood that other embodiments may be utilized without departing fromthe scope of the disclosure.

In various embodiments, ventricular signals are used for determiningsuccessive ventricular cycle lengths for use in detecting atrialarrhythmias. The atrial arrhythmia detection methods do not require anatrial signal source. The methods presented herein may be embodied insoftware, hardware or firmware in implantable or external medicaldevices. Such devices include implantable monitoring devices havingcardiac EGM/ECG monitoring capabilities and associated EGM/ECG senseelectrodes, which may be intracardiac, epicardial, or subcutaneouselectrodes.

The methods described herein can also be incorporated in implantablemedical devices having therapy delivery capabilities, such as singlechamber or bi-ventricular pacing systems or ICDs that sense the R-wavesin the ventricles and deliver an electrical stimulation therapy to theventricles. The atrial arrhythmia detection methods presently disclosedmay also be incorporated in external monitors having ECG electrodescoupled to the patient's skin to detect R-waves, e.g. Holter monitors,or within computerized systems that analyze pre-recorded ECG or EGMdata. Embodiments may further be implemented in a patient monitoringsystem, such as a centralized computer system which processes data sentto it by implantable or wearable monitoring devices.

FIG. 1 is a schematic diagram of an exemplary medical device fordetecting arrhythmia during ventricular pacing according to anembodiment of the present disclosure. As illustrated in FIG. 1, amedical device according to an embodiment of the present disclosure maybe in the form of an implantable cardioverter defibrillator (ICD) 10 aconnector block 12 that receives the proximal ends of a rightventricular lead 16, a right atrial lead 15 and a coronary sinus lead 6,used for positioning electrodes for sensing and stimulation in three orfour heart chambers. Right ventricular lead 16 is positioned such thatits distal end is in the right ventricle for sensing right ventricularcardiac signals and delivering pacing or shocking pulses in the rightventricle. For these purposes, right ventricular lead 16 is equippedwith a ring electrode 24, an extendable helix electrode 26 mountedretractably within an electrode head 28, and a coil electrode 20, eachof which are connected to an insulated conductor within the body of lead16. The proximal end of the insulated conductors are coupled tocorresponding connectors carried by bifurcated connector 14 at theproximal end of lead 16 for providing electrical connection to the ICD10. It is understood that although the device illustrated in FIG. 1 is adual chamber device, other devices such as single chamber devices may beutilized to perform the technique of the present disclosure describedherein.

The right atrial lead 15 is positioned such that its distal end is inthe vicinity of the right atrium and the superior vena cava. Lead 15 isequipped with a ring electrode 21 and an extendable helix electrode 17,mounted retractably within electrode head 19, for sensing and pacing inthe right atrium. Lead 15 is further equipped with a coil electrode 23for delivering high-energy shock therapy. The ring electrode 21, thehelix electrode 17 and the coil electrode 23 are each connected to aninsulated conductor with the body of the right atrial lead 15. Eachinsulated conductor is coupled at its proximal end to a connectorcarried by bifurcated connector 13.

The coronary sinus lead 6 is advanced within the vasculature of the leftside of the heart via the coronary sinus and great cardiac vein. Thecoronary sinus lead 6 is shown in the embodiment of FIG. 1 as having adefibrillation coil electrode 8 that may be used in combination witheither the coil electrode 20 or the coil electrode 23 for deliveringelectrical shocks for cardioversion and defibrillation therapies. Inother embodiments, coronary sinus lead 6 may also be equipped with adistal tip electrode and ring electrode for pacing and sensing functionsin the left chambers of the heart. The coil electrode 8 is coupled to aninsulated conductor within the body of lead 6, which provides connectionto the proximal connector 4.

The electrodes 17 and 21 or 24 and 26 may be used as true bipolar pairs,commonly referred to as a “tip-to-ring” configuration. Further,electrode 17 and coil electrode 20 or electrode 24 and coil electrode 23may be used as integrated bipolar pairs, commonly referred to as a“tip-to-coil” configuration. In accordance with the invention, ICD 10may, for example, adjust the electrode configuration from a tip-to-ringconfiguration, e.g., true bipolar sensing, to a tip-to-coilconfiguration, e.g., integrated bipolar sensing, upon detection ofoversensing in order to reduce the likelihood of future oversensing. Inother words, the electrode polarities can be reselected in response todetection of oversensing in an effort to reduce susceptibility ofoversensing. In some cases, electrodes 17, 21, 24, and 26 may be usedindividually in a unipolar configuration with the device housing 11serving as the indifferent electrode, commonly referred to as the “can”or “case” electrode.

The device housing 11 may also serve as a subcutaneous defibrillationelectrode in combination with one or more of the defibrillation coilelectrodes 8, 20 or 23 for defibrillation of the atria or ventricles. Itis recognized that alternate lead systems may be substituted for thethree lead system illustrated in FIG. 1. While a particularmulti-chamber ICD and lead system is illustrated in FIG. 1,methodologies included in the present invention may adapted for use withany single chamber, dual chamber, or multi-chamber ICD or pacemakersystem, subcutaneous implantable device, or other internal or externalcardiac monitoring device.

FIG. 2 is a functional schematic diagram of the medical device ofFIG. 1. This diagram should be taken as exemplary of the type of devicewith which the invention may be embodied and not as limiting. Thedisclosed embodiment shown in FIG. 2 is a microprocessor-controlleddevice, but the methods of the present invention may also be practicedwith other types of devices such as those employing dedicated digitalcircuitry.

With regard to the electrode system illustrated in FIG. 1, ICD 10 isprovided with a number of connection terminals for achieving electricalconnection to the leads 6, 15, and 16 and their respective electrodes. Aconnection terminal 311 provides electrical connection to the housing 11for use as the indifferent electrode during unipolar stimulation orsensing. The connection terminals 320, 313, and 318 provide electricalconnection to coil electrodes 20, 8 and 23 respectively. Each of theseconnection terminals 311, 320, 313, and 318 are coupled to the highvoltage output circuit 234 to facilitate the delivery of high energyshocking pulses to the heart using one or more of the coil electrodes 8,20, and 23 and optionally the housing 11.

The connection terminals 317 and 321 provide electrical connection tothe helix electrode 17 and the ring electrode 21 positioned in the rightatrium. The connection terminals 317 and 321 are further coupled to anatrial sense amplifier 204 for sensing atrial signals such as P-waves.The connection terminals 326 and 324 provide electrical connection tothe helix electrode 26 and the ring electrode 24 positioned in the rightventricle. The connection terminals 326 and 324 are further coupled to aventricular sense amplifier 200 for sensing ventricular signals. Theatrial sense amplifier 204 and the ventricular sense amplifier 200preferably take the form of automatic gain controlled amplifiers withadjustable sensitivity. In accordance with the invention, ICD 10 and,more specifically, microprocessor 224 automatically adjusts thesensitivity of atrial sense amplifier 204, ventricular sense amplifier200 or both in response to detection of oversensing in order to reducethe likelihood of oversensing. Ventricular sense amplifier 200 andatrial sense amplifier 204 operate in accordance with originallyprogrammed sensing parameters for a plurality of cardiac cycles, andupon detecting oversensing, automatically provides the corrective actionto avoid future oversensing. In this manner, the adjustments provided byICD 10 to amplifiers 200 and 204 to avoid future oversensing are dynamicin nature. Particularly, microprocessor 224 increases a sensitivityvalue of the amplifiers, thus reducing the sensitivity, when oversensingis detected. Atrial sense amplifier 204 and ventricular sense amplifier200 receive timing information from pacer timing and control circuitry212.

Specifically, atrial sense amplifier 204 and ventricular sense amplifier200 receive blanking period input, e.g., ABLANK and VBLANK,respectively, which indicates the amount of time the electrodes are“turned off” in order to prevent saturation due to an applied pacingpulse or defibrillation shock. As will be described, the blankingperiods of atrial sense amplifier 204 and ventricular sense amplifier200 and, in turn, the blanking periods of sensing electrodes associatedwith the respective amplifiers may be automatically adjusted by ICD 10to reduce the likelihood of oversensing. The general operation of theventricular sense amplifier 200 and the atrial sense amplifier 204 maycorrespond to that disclosed in U.S. Pat. No. 5,117,824, by Keimel, etal., incorporated herein by reference in its entirety. Whenever a signalreceived by atrial sense amplifier 204 exceeds an atrial sensitivity, asignal is generated on the P-out signal line 206. Whenever a signalreceived by the ventricular sense amplifier 200 exceeds a ventricularsensitivity, a signal is generated on the R-out signal line 202.

Switch matrix 208 is used to select which of the available electrodesare coupled to a wide band amplifier 210 for use in digital signalanalysis. Selection of the electrodes is controlled by themicroprocessor 224 via data/address bus 218. The selected electrodeconfiguration may be varied as desired for the various sensing, pacing,cardioversion and defibrillation functions of the ICD 10. Specifically,microprocessor 224 may modify the electrode configurations based ondetection of oversensing due to cardiac or non-cardiac origins. Upondetection of R-wave oversensing, for example, microprocessor 224 maymodify the electrode configuration of the right ventricle from truebipolar sensing, e.g., tip-to-ring, to integrated bipolar sensing, e.g.,tip-to-coil.

Signals from the electrodes selected for coupling to bandpass amplifier210 are provided to multiplexer 220, and thereafter converted tomulti-bit digital signals by A/D converter 222, for storage in randomaccess memory 226 under control of direct memory access circuit 228 viadata/address bus 218. Microprocessor 224 may employ digital signalanalysis techniques to characterize the digitized signals stored inrandom access memory 226 to recognize and classify the patient's heartrhythm employing any of the numerous signal processing methodologiesknown in the art. An exemplary tachyarrhythmia recognition system isdescribed in U.S. Pat. No. 5,545,186 issued to Olson et al, incorporatedherein by reference in its entirety.

Upon detection of an arrhythmia, an episode of EGM data, along withsensed intervals and corresponding annotations of sensed events, arepreferably stored in random access memory 226. The EGM signals storedmay be sensed from programmed near-field and/or far-field sensingelectrode pairs. Typically, a near-field sensing electrode pair includesa tip electrode and a ring electrode located in the atrium or theventricle, such as electrodes 17 and 21 or electrodes 26 and 24. Afar-field sensing electrode pair includes electrodes spaced furtherapart such as any of: the defibrillation coil electrodes 8, 20 or 23with housing 11; a tip electrode 17 or 26 with housing 11; a tipelectrode 17 or 26 with a defibrillation coil electrode 20 or 23; oratrial tip electrode 17 with ventricular ring electrode 24. The use ofnear-field and far-field EGM sensing of arrhythmia episodes is describedin U.S. Pat. No. 5,193,535, issued to Bardy, incorporated herein byreference in its entirety. Annotation of sensed events, which may bedisplayed and stored with EGM data, is described in U.S. Pat. 4,374,382issued to Markowitz, incorporated herein by reference in its entirety.

The telemetry circuit 330 receives downlink telemetry from and sendsuplink telemetry to an external programmer, as is conventional inimplantable anti-arrhythmia devices, by means of an antenna 332. Data tobe uplinked to the programmer and control signals for the telemetrycircuit are provided by microprocessor 224 via address/data bus 218. EGMdata that has been stored upon arrhythmia detection or as triggered byother monitoring algorithms may be uplinked to an external programmerusing telemetry circuit 330. Received telemetry is provided tomicroprocessor 224 via multiplexer 220. Numerous types of telemetrysystems known in the art for use in implantable devices may be used.

The remainder of the circuitry illustrated in FIG. 2 is an exemplaryembodiment of circuitry dedicated to providing cardiac pacing,cardioversion and defibrillation therapies. The pacer timing and controlcircuitry 212 includes programmable digital counters which control thebasic time intervals associated with various single, dual ormulti-chamber pacing modes or anti-tachycardia pacing therapiesdelivered in the atria or ventricles. Pacer circuitry 212 alsodetermines the amplitude of the cardiac pacing pulses under the controlof microprocessor 224.

During pacing, escape interval counters within pacer timing and controlcircuitry 212 are reset upon sensing of R-waves or P-waves as indicatedby signals on lines 202 and 206, respectively. In accordance with theselected mode of pacing, pacing pulses are generated by atrial paceroutput circuit 214 and ventricular pacer output circuit 216. The paceroutput circuits 214 and 216 are coupled to the desired electrodes forpacing via switch matrix 208. The escape interval counters are resetupon generation of pacing pulses, and thereby control the basic timingof cardiac pacing functions, including anti-tachycardia pacing.

The durations of the escape intervals are determined by microprocessor224 via data/address bus 218. The value of the count present in theescape interval counters when reset by sensed R-waves or P-waves can beused to measure R-R intervals and P-P intervals for detecting theoccurrence of a variety of arrhythmias.

The microprocessor 224 includes associated read-only memory (ROM) inwhich stored programs controlling the operation of the microprocessor224 reside. A portion of the random access memory (RAM) 226 may beconfigured as a number of recirculating buffers capable of holding aseries of measured intervals for analysis by the microprocessor 224 forpredicting or diagnosing an arrhythmia. In response to the detection oftachycardia, anti-tachycardia pacing therapy can be delivered by loadinga regimen from microprocessor 224 into the pacer timing and controlcircuitry 212 according to the type of tachycardia detected. In theevent that higher voltage cardioversion or defibrillation pulses arerequired, microprocessor 224 activates the cardioversion anddefibrillation control circuitry 230 to initiate charging of the highvoltage capacitors 246 and 248 via charging circuit 236 under thecontrol of high voltage charging control line 240. The voltage on thehigh voltage capacitors is monitored via a voltage capacitor (VCAP) line244, which is passed through the multiplexer 220. When the voltagereaches a predetermined value set by microprocessor 224, a logic signalis generated on the capacitor full (CF) line 254, terminating charging.The defibrillation or cardioversion pulse is delivered to the heartunder the control of the pacer timing and control circuitry 212 by anoutput circuit 234 via a control bus 238. The output circuit 234determines the electrodes used for delivering the cardioversion ordefibrillation pulse and the pulse wave shape.

In one embodiment, the ICD 10 may be equipped with a patientnotification system 150. Any patient notification method known in theart may be used such as generating perceivable twitch stimulation or anaudible sound. A patient notification system may include an audiotransducer that emits audible sounds including voiced statements ormusical tones stored in analog memory and correlated to a programming orinterrogation operating algorithm or to a warning trigger event asgenerally described in U.S. Pat. No. 6,067,473 issued to Greeninger etal., incorporated herein by reference in its entirety.

FIG. 3 is a schematic exemplary diagram of classifying of cardiac eventsin a cardiac medical device according to an embodiment of the presentdisclosure. Methods have been developed for detecting atrial arrhythmiasbased on the irregularity of ventricular cycles measured by RR intervalsthat exhibit discriminatory signatures when plotted in a Lorenz scatterplot such as the plot shown in FIG. 3. One such method is generallydisclosed by Ritscher et al. in U.S. Patent No. 7,031,765, incorporatedherein by reference in its entirety. Other methods are generallydisclosed by Sarkar, et al. in U.S. Patent No. 7,623,911 and in U.S.Pat. No. 7,537,569 and by Houben in U.S. Pat. No. 7,627,368, all ofwhich patents are also incorporated herein by reference in theirentirety. Therefore, according to one embodiment, in order to determinewhether an atrial fibrillation event is occurring, the device may plotRR intervals between determined sensed R-waves using a Lorentz scatterplot and make the decision as to whether an atrial fibrillation event isoccurring based on the resulting interval differences determined fromthe plotted intervals. While the method of distinguishing atrial eventsaccording to the present disclosure is described using a scatter plot todetermine RR intervals that exhibit discriminatory signatures, it isunderstood that the present disclosure may be utilized as part of anyknown methods for discriminating atrial fibrillation events.

In particular, as illustrated in FIG. 3, during the generation of aLorenz scatter plot of VCL data for use in detecting atrial arrhythmias,the differences between consecutive RR intervals (δRRs) are plotted fora time series of R-R intervals (RRIs). The Lorenz plot 14 is a Cartesiancoordinate system defined by δRR_(i), along the x-axis 18 and δRR_(i-1)along the y-axis 16. As such, each plotted point in a Lorenz plot isdefined by an x-coordinate equaling δRR_(i) and a y-coordinate equalingδRR_(i-1). δRR_(i) is the difference between the i^(th) RRI and theprevious RRI, RRI_(i-1) is the difference between RRI_(i-1) and theprevious RRI, RRI_(i-2). As such, each data point plotted on the Lorenzplot 14 represents a VCL pattern relating to three consecutive VCLs:RRI_(i), RRI_(i-1) and RRI_(i-2), measured between four consecutivelysensed R-waves. As noted previously, VCL information is not limited todetection of R-waves and determination of RRIs. The terms RRI andδRR_(i) as used herein refer generally to a measurement of VCL and thedifference between two consecutive VCL measurements, respectively,whether the VCL measurements were derived from a series of R-wavedetections from an EGM or ECG signal or another ventricular cycle eventdetection from any other physiological signal (e.g. a peak pressuredetermined from a pressure signal). For the sake of illustration, theembodiments described herein often refer to R-wave detections forperforming VCL measurements and the determination of (δRR_(i),δRR_(i-1)) points.

As illustrated in FIG. 3, a series of R-wave events 20 are sensed and inorder to plot a point on the Lorenz plot area 14, a (δRR_(i), δRR_(i-1))point may be determined by measuring successive RRIs determined from theR-wave events 20. In the example shown, a first series 22 of threeconsecutive RRIs (RRI_(i-2), RRI_(i-1) and RRI_(i)) provides the firstdata point on the Lorenz plot area 14. δRR_(i-1), which is thedifference between RRI_(i-2) and is approximately 0. δRR_(i), thedifference between the and RRI_(i-1) and RRI_(i), is a positive change.Accordingly, a (δRR_(i), δRR_(i-1)) point 23 having a y-coordinate near0 and a positive x-coordinate is plotted in the Lorenz plot 14,representing the first series 22.

The next series 24 of three RRIs provides the next (δRR_(i), δRR_(i-1))point 25 having a negative x-cooridinate (RRI_(i), being less thanRRI_(i-1)) and a positive y-coordinate (RRI_(i-1) being greater thanRRI_(i-2)). This process of plotting (δRR_(i), δRR_(i-1)) pointscontinues with the three cycle series 26 providing data point 27 and soon.

FIG. 4 is a diagram of an exemplary two-dimensional histogramrepresenting a Lorenz plot area for identifying cardiac events.Generally, the Lorenz plot area 14 shown in FIG. 4 is numericallyrepresented by a two-dimensional histogram 160 having predefined ranges166 and 164 in both positive and negative directions for the δRR_(i)andδRR_(i-1) coordinates, respectively. The two-dimensional histogram isdivided into bins 168 each having a predefined range of δRR_(i) andδRR_(i-1) values. In one example, the histogram range might extend from−1200 ms to +1200 ms for both δRR_(i) and δRR_(i-1) values, and thehistogram range is divided into bins extending 7.5 ms in each of the twodimensions resulting in a 160 bin×160 bin histogram. The successive RRIdifferences determined over a detection time interval are used topopulate the histogram 160. Each bin stores a count of the number of(δRR_(i), δRR_(i-1) ) data points falling into the bin range. The bincounts may then be used in determining RRI variability metrics andpatterns for determining a cardiac rhythm type.

An RRI variability metric is determined from the scatter plot.Generally, the more histogram bins that are occupied, i.e. the moresparse the distribution of (δRR_(i), δRR_(i-1)) points, the moreirregular the VCL during the data acquisition time period. As such, ametric of the RRI variability can be used for detecting atrialfibrillation, which is associated with highly irregular VCL. In oneembodiment, an RRI variability metric for detecting AF, referred to asan AF score is computed as generally described in the above-incorporated'911 patent. Briefly, the AF score may be defined by the equation:

AF Evidence=Irregularity Evidence−Origin Count−PAC Evidence

wherein Irregularity Evidence is the number of occupied histogram binsoutside a Zero Segment defined around the origin of the Lorenz plotarea. During normal sinus rhythm or highly organized atrial tachycardia,nearly all points will fall into the Zero Segment because of relativelysmall, consistent differences between consecutive RRIs. A high number ofoccupied histogram bins outside the Zero segment is therefore positiveevidence for AF.

The Origin Count is the number of points in a “Zero Segment” definedaround the Lorenz plot origin. A high Origin Count indicates regularRRIs, a negative indicator of atrial fibrillation, and is thereforesubtracted from the Irregularity Evidence term. In addition, a regularPAC evidence score may be computed as generally described in theabove-incorporated '911 patent. The regular PAC evidence score iscomputed based on a cluster signature pattern of data points that isparticularly associated with PACs that occur at regular couplingintervals and present regular patterns of RRIs, e.g. associated withbigeminy (short-short-long RRIs) or trigeminy (short-short-short-longRRIs).

In other embodiments, an AF score or other RRI variability score forclassifying an atrial rhythm may be computed as described in any of theabove-incorporated '765, '316, '911, '569 and '368 patents.

The AF score is compared to an AF threshold for detecting atrialfibrillation to determine whether the AF score corresponds to an AFevent. The AF threshold may be selected and optimized based onhistorical clinical data of selected patient populations or historicalindividual patient data, and the optimal threshold setting may vary frompatient to patient. If the metric crosses a detection threshold, AFdetection occurs. A response to AF detection is made, either in responseto a classification of a single two second time interval as being AF,i.e., being greater than the AF threshold, or in response to apredetermined number of two second intervals being classified as beingan AF event by each being greater than the AF threshold. Such responseto the AF detection may include withholding or altering therapy, such asa ventricular therapy, for example, storing data that can be laterretrieved by a clinician, triggering an alarm to the patient or that maybe sent remotely to alert the clinician, delivering or adjusting atherapy, and triggering other signal acquisition or analysis.

The RRI measurements may continue to be performed after an AF detectionto fill the histogram during the next detection time interval. Aftereach detection time interval, the RRI variability metric is determinedand the histogram bins are re-initialized to zero for the next detectiontime interval. The new RRI variability metric determined at the end ofeach data acquisition interval may be used to determine if the AFepisode is sustained or terminated.

FIG. 5 is a flowchart of a method of generating a template fordetermining atrial fibrillation events in a medical device according toan embodiment of the present disclosure. Flow charts presented hereinare intended to illustrate the functional operation of the device, andshould not be construed as reflective of a specific form of software orhardware necessary to practice the invention. It is believed that theparticular form of software will be determined primarily by theparticular system architecture employed in the device and by theparticular detection and therapy delivery methodologies employed by thedevice. Providing software to accomplish the present invention in thecontext of any modern IMD, given the disclosure herein, is within theabilities of one of skill in the art.

Methods described in conjunction with flow charts presented herein maybe implemented in a computer-readable medium that includes instructionsfor causing a programmable processor to carry out the methods described.A “computer-readable medium” includes but is not limited to any volatileor non-volatile media, such as a RAM, ROM, CD-ROM, NVRAM, EEPROM, flashmemory, and the like. The instructions may be implemented as one or moresoftware modules, which may be executed by themselves or in combinationwith other software.

As illustrated in FIG. 5, according to one embodiment, in order togenerate a P-wave template, the device identifies a predetermined numberof normal R-waves, i.e., R-waves associated with non-paced, slowrhythms, having a desired R-wave morphology, Block 300. Thepredetermined number of normal cardiac intervals, which may be eitherconsecutive intervals or nonconsecutive intervals, are then used togenerate the P-wave template, as described below in detail. For example,the device identifies an RR-interval from a QRS signal resulting fromthe sensed cardiac signal, and identifies the interval as being a normalcardiac interval if both the RR-interval is greater than a predeterminenormal interval threshold, such 600 milliseconds, for example, and amorphology match of the RR-interval matches a predetermined morphologymatching threshold. The morphology match may be determined using a knownwaveform matching scheme, such as a wavelet transform analysis scheme,or other known morphology matching scheme. Examples of ECG templateacquisition and ECG signal analysis methods are generally disclosed inU.S. Pat. No. 6,393,316 to Gillberg, et al., U.S. Pat. No. 7,062,315 toKoyrakh, et al., and U.S. Pat. No. 7,996,070 to van Dam et al.,incorporated herein by reference in their entireties.

According to one embodiment, for example, the device may determinewhether four R-waves associated with four identified normal cardiacRR-intervals each have an individual predetermined morphology matchscore that identifies the R-wave as having a desired R-wave morphology.If one or more of the R-waves do not have the predetermined morphologymatch score identifying the R-wave as having the desired R-wavemorphology, the process of identifying the predetermined number ofR-waves is repeated to generate a new predetermined number of normalR-waves, and morphology matches are again determined for the newlygenerated normal R-waves, Block 300.

Once the predetermined number of normal R-waves having correspondingR-waves with the desired R-wave morphology are identified in Block 300,the device determines a P-wave window for each of the predeterminednumber of R-waves, Block 302. The P-wave window is used to identify aP-wave associated with each R-wave. Upon identification of the P-waveusing the P-wave window, the device performs a P-wave adjustment foreach identified P-wave, Block 304, and determines P-wave templateparameters associated with each P-wave, Block 306, as will be describedin detail below. Once the P-waves associated with each of the R-waveshave been identified, Block 302, the P-wave adjustment has been made,Block 304, and the P-wave template parameters have been determined,Block 306, for each of the predetermined number of P-waves, No in Block308, the device determines whether the P-waves are valid templategeneration waveforms, Block 310, using the determined P-wave templateparameters, Block 306, as will be described in detail below. If any ofthe predetermined P-waves are determined not to be a valid templategeneration waveform, No in Block 310, the process of identifying thepredetermined number of normal RR-intervals is repeated to generate newresulting R-waves, morphology matches are again determined for the newlygenerated R-waves, Block 300, and the waveform validation process Blocks302-310, is repeated. If all of the predetermined P-waves are determinedto be valid template generation waveforms, Yes in Block 310, the P-wavetemplate is generated using the valid waveforms, Block 312, as will bedescribed in detail below.

FIGS. 6A and 6B are schematic diagrams of identifying a P-wave portionof a sensed cardiac signal in a medical device according to anembodiment of the present disclosure. As illustrated in FIG. 6A, thedevice identifies four normal RR-intervals 320-326 associated with foursensed R-waves 328-334 of a sensed cardiac signal 336, and determinesthat the corresponding R-waves 328-334 each have the desired R-wavemorphology, as described above. In order to identify a P-wave portion338 for each of the predetermined number of R-waves 328-334, the devicedetermines a P-wave window 340 for each R-wave 328-334. For example, asillustrated in FIG. 6B, in order to determine the P-wave window 340associated with each R-wave 328-334, the device determines a P-wavewindow start point 342 and a P-wave window end point 344 based onsensing of the R-wave 328-334. For example, the P-wave window startpoint 342 is determined to be located a predetermined distance 346 priorto a Vs event 348 associated with the identified R-wave 328 of thecardiac signal 336, and the corresponding P-wave window end point 344 isdetermined to extend a predetermined distance 350 from the P-wave windowstart point 342, such as 242 ms, for example.

FIG. 7 is a graphical representation of determining of a P-wave windowstart point based on a sensed R-wave for generating a template duringdetermining of atrial fibrillation events in a medical device accordingto an embodiment of the present disclosure. According to one embodiment,the location of the window start point 342 relative to the Vs event 348may be dependent upon the heart rate associate with the Vs sense event348 for determining the RR-interval 320. For example, for R-wave 328,the device determines whether a length of the RR interval 320 betweenR-wave 328 and a previous R-wave 352 is greater than a predetermined RRinterval threshold, such as 700 ms, for example, and sets the locationof the window start point 342 based on the result.

In particular, according to one embodiment, if RR-interval 320 isgreater than the RR-interval threshold, the predetermined distance 346is set as a baseline distance of 460 ms, for example. However, if RRinterval 320 is not greater than the RR-interval threshold, thepredetermined distance 346 may be reduced from the baseline distance byan amount relative to the length of the determined RR interval 320. Forexample, according to one embodiment, the reduction in the distance 346may as determined from the graph illustrated in FIG. 7, so that if theRR interval 320 is 600 ms, for example, the distance 346 is reduced from460 ms to 406 ms; if the RR interval 320 is 500 ms, the distance 346 isreduced to 350 ms; and if the RR interval 320 is 400 ms, the distance346 is reduced to 296 ms, and so forth. According to one embodiment, adistance 345 that the end point 344 is located relative to the Vs senseevent 348 remains the same regardless of the location of the start point342. For example, the distance 345 may be set as being the distanceutilized when the length of the RR interval 320 between R-wave 328 and aprevious R-wave 352 is greater than the predetermined RR intervalthreshold, during which the distance 345 is set as being approximatelyequal to 218 ms (460 ms−242 ms). In this way, as the magnitude of the RRintervals decreases, the width 346 of the P-wave window 342 is reducedsince the distance 346 is reduced.

FIGS. 8A and 8B are schematic diagrams of determining of P-wave templateparameters in a medical device according to an embodiment of the presentdisclosure. As can been seen in FIGS. 6A, 8A and 8B, in some instancesthe P-wave 328 may be shaped such that a beginning portion of the P-wavealong the cardiac signal 336 is located at an amplitude that differsfrom an amplitude of an ending portion of the P-wave 328, resulting in aphenomena known as baseline wander. In order to account for thisbaseline wander, the device may determine a first baseline wander window356 associated with the beginning portion of the P-wave and a secondbaseline wander window 358 associated with the ending portion of theP-wave. For example, according to one embodiment, illustrated in FIG.6B, the device may determine that windows 356 and 358 are locatedoutside of the P-wave window 340, with the first baseline wander window356 extending between the P-wave window start point 342 and a baselinewindow start point 360 located a predetermined distance 347 prior to theP-wave window start point 342, such as 30 ms, for example, and thesecond baseline wander window 358 extending between the P-wave windowend point 344 and a baseline window endpoint 362 located a predetermineddistance from the P-wave window end point 344, such as 30 ms, forexample. The device then determines both a first baseline end point 366located within the first baseline wander window 356, and a secondbaseline end point 368 located within the second baseline wander window358 based on the cardiac signal 336 within the respective windows 356and 358. For example, endpoint 366 may be determined to be the averageamplitude of the cardiac signal 336 within window 356, and endpoint 368may be determined as being the average amplitude of the cardiac signal336 within window 358. A P-wave baseline 370 therefore is determined toextend between endpoint 366 and endpoint 368, so that a linearadjustment of the P-wave is made by adjusting a slope of the baseline370, resulting in a baseline adjusted P-wave 372 having approximatelyzero slope.

The device determines whether an absolute value of a maximum amplitudeof the baseline adjusted P-wave 372 is greater than or equal to anabsolute value of a minimum amplitude. If the absolute value of themaximum amplitude is greater than or equal to the absolute minimumamplitude, a maximum amplitude 374 of the baseline adjusted P-wave 372is set equal to the absolute maximum amplitude, and the negative portionof the wave form 372 is set equal to zero. On the other hand, if theabsolute value of the maximum amplitude is not greater than or equal tothe absolute minimum amplitude, a maximum amplitude 374 of the baselineadjusted P-wave 372 is set equal to the absolute minimum amplitude, andthe positive portion of the wave form 372 is set equal to zero.

The device determines a first minimum amplitude point 376 located alonga first side of the adjusted P-wave 372 and a second minimum amplitudepoint 378 located along a second side of the adjusted P-wave 372opposite the first side. According to an embodiment, the first minimumamplitude point 376 and the second minimum amplitude point 378 may bedetermined based on the maximum amplitude. For example, the devicedetermines the first and second minimum points 376 and 378 as beinglocated along the waveform 372 at a portion of the maximum amplitude374, such as one sixteenth of the maximum amplitude 374, for example.The device then determines the area of a portion 380 (shown in hashedmarks) of the adjusted P-wave 372 defined by a baseline 382 extendingbetween points 376 and 378 of the adjusted P-wave 372.

In order to subsequently align the current four P-waves 338, the devicedetermines a center of area 384 of each of the P-waves 338. According toone embodiment, for example, in order to approximate the center of area384 of a P-wave, the device normalizes the area of the portion 380 ofthe adjusted P-wave 372 by determining a P-wave center window 386 thatis a normalized rectangular version of the adjusted P-wave 372, havingone side corresponding to the baseline 382 and an area approximating thearea of the portion 380 of the P-wave 372 formed by baseline 382 and thedetermined maximum amplitude 374. Using the determined baseline 382 andarea of the portion 380 of the P-wave 372, the device determines anormalized amplitude 388 of P-wave center window 386, and an approximatecenter of area 384 of the adjusted P-wave 372 is calculated based on theamplitude 388 and width 382 of the normalized center window 386. Thisdetermination of the linear adjustment of the P-wave and the approximatecenter of area 384 using a normalized center window 386 is performed foreach P-wave 328 of the determined R-waves 328-334, and subsequentlyutilized to generate a P-wave template, and confirm a detected AF event,as described below.

FIG. 9 is a flowchart of a method for generating a template fordetermining an atrial fibrillation event in a medical device accordingto an embodiment of the present disclosure. As illustrated in FIG. 9,according to one embodiment, during generating of a P-wave template, thedevice senses four R-waves 328-334 and identifies four correspondingP-waves 338, as described above. For each P-wave 338, the devicedetermines the P-wave window 342, Block 400, as described above, anddetermines whether a maximum amplitude of the P-wave located within thewindow 342, Block 402, is greater than an amplitude threshold, Block404. If the maximum amplitude is not greater than the maximum amplitudethreshold, No in Block 404, the waveform is determined not to be aP-wave, Block 406, the current four P-waves are therefore discarded, andthe process is repeated with the next four determined P-waves.

If the maximum amplitude is greater than the maximum amplitudethreshold, Yes in Block 404, the device determines the adjusted P-wave,Block 408, and the normalized P-wave parameters, Block 410, resultingfrom the normalized P-wave window 386, such as the width 382 andamplitude 388 of the normalized P-wave center window 386, describedabove. When the determination of Blocks 400-410 has been made for eachof the four P-waves 328, No in Block 412, the device utilizes thedetermined parameters to determine an average P-wave width 382, Block414, and an average P-wave normalized amplitude 388, Block 416, for thefour P-waves 328. A determination is then made for each of the P-waves328, as to whether each of the P-waves 328 match each other within apredetermined P-wave match threshold, Block 418, indicative of thelikelihood that the waveform is a P-wave.

FIG. 10 is a flowchart of determining P-wave matching in a medicaldevice according to an embodiment of the present disclosure. Accordingto one embodiment, in order to make the determination as to whether aP-wave 328 matches the P-wave threshold in Block 418, the devicedetermines, for each one of the four P-waves, a corresponding relativewidth change, Block 424, by determining the absolute value of thedifference between the width associated with baseline 382 extendingbetween points 376 and 378 of the adjusted P-wave 372 for each P-wave328, and the average width determined for the four P-waves (Block 414 ofFIG. 9). The width change is compared to a width change threshold, Block426, and if the width change is not less than the width changethreshold, No in Block 426, the waveform is determined not to be aP-wave, Block 428, and the next four R-waves and corresponding P-wavesare determined, as described above, and the process is repeated usingthe next four P-waves.

If the width change is less than the width change threshold, Yes inBlock 426, the device determines a relative normalized amplitude changefor the P-wave, Block 430, by determining the absolute value of thedifference between the maximum normalized amplitude 388 of the P-wave372 and the average amplitude determined for the current four P-waves(Block 416 of FIG. 9). The amplitude change is compared to an amplitudechange threshold, Block 432, and if the amplitude change is not lessthan the amplitude change threshold, No in Block 432, the waveform isdetermined not to be a P-wave, Block 428, and the next four R-waves andcorresponding P-waves are determined, as described above, and theprocess is repeated using the next four P-waves. If the amplitude changeis determined to be less than the amplitude change threshold, Yes inBlock 432, the device determines the magnitude of the P-wave bydetermining the distance between the baseline 382 and the maximumamplitude 374, Block 434, and compares the determined P-wave magnitudeto a magnitude threshold, Block 436. If the P-wave magnitude is lessthan the magnitude threshold, Yes in Block 436, the waveform isdetermined not to be a P-wave, Block 428, and the next four R-waves andcorresponding P-waves are determined, as described above, and theprocess is repeated using the next four P-waves. If the P-wave magnitudeis not less than the magnitude threshold, No in Block 436, the P-wave isdetermined to match the P-wave threshold, and the process is repeatedwith the next P-wave 328 until all four P-waves 323 have been determinedto match the P-wave threshold, Block 440.

According to one embodiment, the width change threshold and theamplitude change threshold are set equal to 62.5 percent, and themagnitude threshold is set as 50 percent, for example.

Returning to FIG. 9, if all four of the P-waves 328 are determined tomatch the P-wave threshold using the process described in FIG. 10, Yesin block 418, the device aligns the peaks of three of the P-waves to thepeak of the remaining P-wave using the determined center of areas 382.For example, according to one embodiment, the last three P-waves arealigned to the first P-wave. The device determines an average P-waveresulting from the aligned P-waves, which is then set as the P-wavetemplate, Block 422, for subsequent use in identifying P-waves.

FIGS. 11A and 11 B are flowcharts of detecting an atrial arrhythmia in acardiac medical device according to an embodiment of the presentdisclosure. As illustrated in FIGS. 11A and 11 B, according to oneembodiment, the device identifies an AF arrhythmia event using any knownAF detection scheme, such as the AF detection scheme described above,for example. As illustrated in FIG. 11 A, upon detection of an AF event,Block 500, the device identifies four slow, non-paced beats, resultingin four R-waves, and using the process described above, determines aP-wave window, Block 502, and an adjusted P-wave, Block 504, for eachR-wave, along with P-wave parameters, Block 506, such as the width 382and the normalized amplitude 388 associated with the adjusted P-wave372. When the parameters 506 have been determined for all four P-waves,Yes in Block 508, the device utilizes the determined parameters todetermine an average P-wave width, Block 510, based on an average of thefour P-wave widths, and an average P-wave amplitude, Block 512, based onthe average of the four P-wave amplitudes. A determination is then madefor each of the P-waves as to whether each of the P-waves match eachother within a predetermined P-wave match threshold, Block 514,indicative of the likelihood that the waveform is a P-wave.

According to one embodiment, in order to make the determination as towhether a P-wave matches the P-wave threshold in Block 514, the devicedetermines, in a manner similar to the scheme for generating a P-wavetemplate described above, a corresponding relative width change, arelative amplitude change, and a P-wave magnitude for each one of thefour P-waves. In particular, order to determine the width change, thedevice determines the absolute value of the difference between the widthassociated with baseline 382 of the adjusted P-wave 372 for each P-waveand the average width determined for the four P-waves. The width changeis then compared to a width change threshold. To determine the amplitudechange, the device determines the absolute value of the differencebetween the maximum normalized amplitude 388 of the P-wave 328 and theaverage normalized amplitude determined for the current four P-waves328, and compares the normalized amplitude change to an amplitude changethreshold. Finally, in order to determine the magnitude of the P-wavethe device determines the distance between the baseline 382 and themaximum amplitude 374 for each of the P-waves, and compares thedetermined P-wave magnitude to a magnitude threshold.

If, for any one of the P-waves, either the width change is not less thanthe width change threshold, the amplitude change is not less than theamplitude change threshold, or the P-wave magnitude is less than themagnitude threshold, the waveform is determined not to be a P-wave, andtherefore all of P-waves do not match the P-wave threshold, No in Block514. As a result, if the AF event continues to be detected, Yes in Block500, the device determines the next four R-waves and correspondingP-waves are determined, as described above, and the process 502-512 isrepeated using the next four P-waves. On the other hand if the widthchange is less than the width change threshold, the amplitude change isless than the amplitude change threshold, and the P-wave magnitude isnot less than the magnitude threshold for each of the P-waves, theP-waves are determined to match the P-wave threshold, Yes in Block 514,and a timer is initiated, Block 516.

According to one embodiment, during AF detection the width changethreshold and the amplitude change threshold are set equal to 50percent, the magnitude threshold is set as 50 percent, and the timerBlock 516 is set as two minutes, for example.

As Illustrated in FIG. 11 B, when the timer is initiated, Block 516, thedevice identifies the next four slow, non-paced beats, resulting in fourR-waves, and using the process described above, determines a P-wavewindow, Block 518 and an adjusted P-wave, Block 520, for each R-wave,along with P-wave parameters, Block 522, such as the width 382 and thenormalized amplitude 388 of the adjusted P-wave 372. When the P-waveparameters have been determined, Block 522, for all four P-waves, Yes inBlock 524, the device utilizes the determined parameters to determine anaverage P-wave width, Block 526, based on an average of the four P-wavewidths, and an average P-wave normalized amplitude, Block 528, based onthe average of the four P-wave normalized amplitudes. A determination isthen made for each of the P-waves as to whether each of the P-wavesmatch each other within a predetermined P-wave match threshold, Block530, indicative of the likelihood that the waveform is a P-wave.

According to one embodiment, in order to make the determination as towhether a P-wave matches the P-wave threshold in Block 530, the devicedetermines, in a manner similar to described above, a correspondingrelative width change, and a relative normalized amplitude change foreach one of the four P-waves, along with a P-wave magnitude. Inparticular, order to determine the width change, the device determinesthe absolute value of the difference between the width associated withbaseline 382 of the adjusted P-wave 372 for each P-wave, and the averagewidth determined for the four P-waves, and compares the width change toa width change threshold. To determine the normalized amplitude change,the device determines the absolute value of the difference between themaximum normalized amplitude 388 of the adjusted P-wave 372 and theaverage normalized amplitude determined for the current four P-waves328, and compares the amplitude change to an amplitude change threshold.Finally, in order to determine the magnitude of the P-wave the devicedetermines the distance between the baseline 382 and the maximumamplitude 374 for each of the P-waves, and compares the determinedP-wave magnitude to a magnitude threshold.

If, for any one of the P-waves, either the width change is not less thanthe width change threshold, the amplitude change is not less than theamplitude change threshold, or the P-wave magnitude is less than themagnitude threshold, the waveform is determined not to be a P-wave, andtherefore all of P-waves do not match the P-wave threshold, No in Block530. On the other hand if the width change is less than the width changethreshold, the amplitude change is less than the amplitude changethreshold, and the P-wave magnitude is not less than the magnitudethreshold for each of the four P-waves, all of P-waves are determined tomatch the P-wave threshold, Yes in Block 514, and a counter, counter thenumber of times four P-waves are determined to match the P-wavethreshold, Yes in Block 530, is increased by one, is increased, Block532.

When either the four P-waves match the P-wave threshold, Yes in Block530, and the counter has been update, or the four P-waves do not matchthe P-wave threshold, No in Block 530, the device determine whether thetimer has expired, Bock 534. If the timer has not expired, No in Block534, and if the AF event continues to be detected, Yes in Block 500, thedevice determines the next four R-waves and corresponding P-waves aredetermined, as described above, and the process 502-512 is repeatedusing the next four P-waves. If the timer has expire, Yes in Block 534,the device determines whether the number of times, i.e, the value of thecounter, Block 532, that the four P-waves were determined to match theP-wave threshold, Yes in Block 530, during the given time period isgreater than or equal to a match threshold, Block 536. If the number oftimes that the four P-waves match the P-wave threshold during the giventime period is greater than or equal to a match threshold, Yes in Block536, the event is determined to be an AF event, and the device mayperform any function or combination of functions, such as delivering atherapy, sounding an alarm, storing the determination of an AF eventwithin the device, or transmitting the determination, etc. If the numberof times that the four P-waves match the P-wave threshold during thegiven time period is not greater than or equal to a match threshold, Noin Block 536, the event is determined to be a non-AF event, Bock 540.

According to one embodiment, during AF detection the width changethreshold and the amplitude change threshold are set equal to 62.5percent, the magnitude threshold is set as 50 percent, the timer Block516 is set as two minutes, and the match threshold is set as two, forexample.

FIG. 12 is a flowchart of a method of detecting an atrial arrhythmia ina medical device according to an embodiment of the present disclosure.As illustrated in FIG. 12, according to one embodiment, in order toidentify an AF arrhythmia event, the device determines an AF score overa predetermined time period, Block 600, using the RR-interval AFalgorithm described above, for example, and determines, based on the AFscore once the time period has expired, whether an AF event is detected,Block 602. According to one embodiment, in order to enhance RR-intervalbased AF detection specificity, if an AF event is detected, Yes in Block602, the device determines an AF score over the time period again, Block604. If an AF event has been detected based on AF scores determined overtwo of the time periods, Blocks 600 and 604, Yes in Block 606, thedevice determines an AF score a third time over the time period, Block608, and if the AF event is determined as occurring the third time, Yesin Block 610, the device performs the confirmation of the AF detectionusing the P-wave analysis, Block 612, over the time period or subsequentto the time period, using the P-wave detection scheme described above.According to one embodiment, the time period may be set as two minutes,for example.

If the P-wave analysis determines the event as being an AF event, Yes inBlock 612, a response to the AF detection may include withholding oraltering therapy, such as a ventricular therapy, for example, storingdata that can be later retrieved by a clinician, triggering an alarm tothe patient or that may be sent remotely to alert the clinician,delivering or adjusting a therapy, and triggering other signalacquisition or analysis.

It is understood that while the embodiment illustrated in FIG. 12indicates detection of an AF event taking place over three separate twominute time periods, with the P-wave analysis being include with thethird time period, Block 608, other embodiments could include one, twoor more than two repeated AF detection analyses, and that the P-waveanalysis could be included with any one or combinations of the AFdeterminations. It is also understood that the P-wave template may begenerated either manually during device implant or during an officevisit by the patient, and that the template may be automatically updated(e.g, daily or weekly) by the device. Furthermore, the method may beapplied in any device utilizing an intracardiac EGM, Subcutaneous ECG orsurface ECG vectors, and other implanted or external cardiac rhythmdevices

Thus, an apparatus and method have been presented in the foregoingdescription with reference to specific embodiments. It is appreciatedthat various modifications to the referenced embodiments may be madewithout departing from the scope of the invention as set forth in thefollowing claims.

1. A method of detecting a cardiac event in a medical device,comprising: sensing a cardiac signal; determining RR-intervals inresponse to the sensed cardiac signal; detecting a cardiac event inresponse to the RR-intervals; iteratively sensing a predetermined numberof P-waves in response to detecting the cardiac event; and confirmingthe cardiac event in response to the iteratively sensed P-waves.
 2. Themethod of claim 1, wherein iteratively sensing a predetermined number ofP-waves comprises: determining P-wave parameters associated with eachP-wave of the predetermined number of P-waves; determining relativechanges of the P-waves in response to the determined P-wave parameters;determining whether each of the P-waves match within a match thresholdin response to the determined relative changes; and updating a counterin response to each of the P-waves matching within the match threshold,wherein the cardiac event is confirmed in response to the counterexceeding a counter threshold during a predetermined time period.
 3. Themethod of claim 2, wherein determining relative changes of the P-wavescomprises: determining a width change for each of the P-waves;determining an amplitude change for each of the P-waves; and determininga magnitude change for each P-wave.
 4. The method of claim 1, whereindetecting a cardiac event comprises: determining R-waves associated withthe RR-intervals; determining P-waves in response to the determinedR-waves; determining parameters associated with each P-wave; determiningrelative changes of the P-waves in response to the determinedparameters; and determining whether each of the P-waves match within amatch threshold in response to the determined relative changes.
 5. Themethod of claim 5, further comprising: determining P-wave windows inresponse to the determined R-waves; adjusting P-waves within the P-wavewindows; and determining the P-wave parameters in response to theadjusted P-waves.
 6. The method of claim 5, further comprising:determining a maximum amplitude of each of the P-waves; determining, foreach of the P-waves, a first minimum baseline point and a second minimumbaseline point as a portion of the maximum amplitude; determining anarea of each of the P-waves in response to a baseline extending betweenthe first minimum baseline point and the second minimum baseline point;normalizing the P-waves in response to the area and the baseline; andconfirming the cardiac event in response to the normalized P-wave. 7.The method of claim 6, wherein normalizing the P-waves comprises:determining a normalized amplitude of each of the P-waves; anddetermining a center of area of the normalized P-wave in response to awidth of the baseline and the normalized amplitude.
 8. The method ofclaim 4, wherein determining relative changes of the P-waves comprises:determining a width change for each of the P-waves; determining anamplitude change for each of the P-waves; and determining a magnitudechange for each P-wave.
 9. The method of claim 4, wherein iterativelysensing a predetermined number of P-waves comprises: determining secondRR-intervals in response to the sensed cardiac signal subsequent todetecting the cardiac event; determining second P-wave parametersassociated with P-waves determined in response to the secondRR-interval; determining relative changes of the second P-waves inresponse to the determined second P-wave parameters; determining whethereach of the second P-waves match within a match threshold in response tothe determined relative changes; and updating a counter in response toeach of the P-waves matching within the match threshold, wherein thecardiac event is confirmed in response to the counter exceeding acounter threshold during a predetermined time period.
 10. The method ofclaim 1, wherein the cardiac event is an atrial fibrillation event. 11.A medical device for detecting a cardiac event, comprising: a pluralityof electrodes sensing a cardiac signal; and a processor configured todetermine RR-intervals in response to the sensed cardiac signal, detecta cardiac event in response to the RR-intervals, iteratively sense apredetermined number of P-waves in response to detecting the cardiacevent, and confirm the cardiac event in response to the iterativelysensed P-waves.
 12. The medical device of claim 11, wherein theprocessor is further configured to determine P-wave parametersassociated with each P-wave of the predetermined number of P-waves,determine relative changes of the P-waves in response to the determinedP-wave parameters, determine whether each of the P-waves match within amatch threshold in response to the determined relative changes, andupdate a counter in response to each of the P-waves matching within thematch threshold, wherein the cardiac event is confirmed in response tothe counter exceeding a counter threshold during a predetermined timeperiod.
 13. The medical device of claim 12, wherein the processor isfurther configured to determine a width change for each of the P-waves,determine an amplitude change for each of the P-waves, and determine amagnitude change for each P-wave.
 14. The medical device of claim 11,wherein the processor is further configured to determine R-wavesassociated with the RR-intervals, determine P-waves in response to thedetermined R-waves, determine parameters associated with each P-wave,determine relative changes of the P-waves in response to the determinedparameters, and determine whether each of the P-waves match within amatch threshold in response to the determined relative changes.
 15. Themedical device of claim 14, wherein the processor is further configuredto determine P-wave windows in response to the determined R-waves,adjust P-waves within the P-wave windows, and determine the P-waveparameters in response to the adjusted P-waves.
 16. The medical deviceof claim 15, wherein the processor is further configured to determine amaximum amplitude of each of the P-waves, determine, for each of theP-waves, a first minimum baseline point and a second minimum baselinepoint as a portion of the maximum amplitude, determine an area of eachof the P-waves in response to a baseline extending between the firstminimum baseline point and the second minimum baseline point, normalizethe P-waves in response to the area and the baseline, and confirm thecardiac event in response to the normalized P-wave.
 17. The medicaldevice of claim 16, wherein the processor is further configured todetermine a normalized amplitude of each of the P-waves, and determine acenter of area of the normalized P-wave in response to a width of thebaseline and the normalized amplitude.
 18. The medical device of claim14, wherein the processor is further configured to determine a widthchange for each of the P-waves, determine an amplitude change for eachof the P-waves, and determine a magnitude change for each P-wave. 19.The medical device of claim 14, wherein the processor is furtherconfigured to determine second RR-intervals in response to the sensedcardiac signal subsequent to detecting the cardiac event, determinesecond P-wave parameters associated with P-waves determined in responseto the second RR-interval, determine relative changes of the secondP-waves in response to the determined second P-wave parameters,determine whether each of the second P-waves match within a matchthreshold in response to the determined relative changes, and update acounter in response to each of the P-waves matching within the matchthreshold, wherein the cardiac event is confirmed in response to thecounter exceeding a counter threshold during a predetermined timeperiod.
 20. The medical device of claim 11, wherein the cardiac event isan atrial fibrillation event.
 21. A non-transitory, computer-readablestorage medium storing instructions for causing a processor included ina medical device to perform a method for determining a cardiac event,the method comprising: sensing a cardiac signal; determiningRR-intervals in response to the sensed cardiac signal; detecting acardiac event in response to the RR-intervals; iteratively sensing apredetermined number of P-waves in response to detecting the cardiacevent; and confirming the cardiac event in response to the iterativelysensed P-waves.
 22. A cardiac medical device for detecting a cardiacevent and delivering therapy for treating atrial fibrillation,comprising: an electrode to sense a cardiac signal associated only witha ventricle of a heart and deliver a therapy to the heart; a processorconfigured to determine RR-intervals in response to the sensed cardiacsignal, detect a cardiac event in response to the RR-intervals,iteratively sense a predetermined number of P-waves in response todetecting the cardiac event, and confirm the cardiac event in responseto the iteratively sensed P-waves; and an output circuit to delivertherapy to the heart via the electrode in response to the confirming thecardiac event.
 23. The medical device of claim 22, wherein the processoris further configured to determine whether atrial fibrillation isoccurring in response to the sensed cardiac signal, and deliverventricular pacing therapy via the output circuit during the detecting acardiac event.
 24. The medical device of claim 23, wherein the processoris further configured to determine R-waves associated with theRR-intervals, determine P-waves in response to the determined R-waves,determine parameters associated with each P-wave, determine relativechanges of the P-waves in response to the determined parameters, anddetermine whether each of the P-waves match within a match threshold inresponse to the determined relative changes.
 26. The medical device ofclaim 25, wherein the processor is further configured to determineP-wave windows in response to the determined R-waves, adjust P-waveswithin the P-wave windows, and determine the P-wave parameters inresponse to the adjusted P-waves.
 27. The medical device of claim 26,wherein the processor is further configured to determine a maximumamplitude of each of the P-waves, determine, for each of the P-waves, afirst minimum baseline point and a second minimum baseline point as aportion of the maximum amplitude, determine an area of each of theP-waves in response to a baseline extending between the first minimumbaseline point and the second minimum baseline point, normalize theP-waves in response to the area and the baseline, and confirm thecardiac event in response to the normalized P-wave.
 28. The medicaldevice of claim 27, wherein the processor is further configured todetermine a normalized amplitude of each of the P-waves, and determine acenter of area of the normalized P-wave in response to a width of thebaseline and the normalized amplitude.